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• Alexion Pharmaceuticals is preparing to initiate a Phase III clinical trial of pexelizumab in approximately 3,000 patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass. The trial will assess the safety and efficacy of pexelizumab in reducing the combined incidence of death and myocardial infarction in this patient population.
• Neurocrine Biosciences has initiated the first Phase III clinical trial of NBI-34060 in approximately 500 patients with chronic (primary) insomnia. The Phase III clinical trial is a randomized, double-blind, parallel-group, multicenter study that will evaluate the safety of two doses of NBI-34060 Immediate Release for the long-term treatment of chronic insomnia in adults. The trial will be conducted at approximately 40 medical sites in the United States and Europe.
• Isis Pharmaceuticals has initiated clinical testing of ISIS 104838, an antisense inhibitor of tumor necrosis factor-alpha (TNF-alpha), in rheumatoid arthritis (RA). This Phase II clinical trial will evaluate the ability of ISIS 104838 to reduce the level of TNF-alpha in synovial tissue, the autoimmune target tissue involved in RA, and in blood. The study also will evaluate the biological effect of TNF-alpha inhibition by ISIS 104838 in RA.
• Protein Design Labs has initiated a Phase II clinical study to evaluate its humanized antibody daclizumab (Zenapax) in patients who suffer from chronic, persistent asthma and whose disease is not well controlled with high doses of inhaled corticosteroid therapy. The randomized, double-blind, placebo-controlled clinical trial will be conducted at approximately 22 centers in the United States, with a target enrollment of 120 patients.